Peritoneal cannula



May 31, 1966 F. E, MATTHEWS ETAL 3,253,594

PERITONEAL CANNULA Filed July 5o, 1963 INVENTORS BY l United StatesPatent O 3,253,594 PERITUNEAL CANNULA Frank E. Matthews, 2020 Add Drive,Falls Church, Va., I2`1/1Inl Kevin G. Barry, 905 Hyde Road, SilverSpring,

Filed July 30, 1963. Ser. No. 298,711 Claims. (Cl. 12S-348) Thisinventionrelates generally to a cannula. In particular, the presentinvention is concerned with a peritoneal cannula which can effectivelyseal a perforation in body flesh and which can be retained in positionin the perforation along with any tubular element which is inl sertablethrough the cannula.

A number of insertion devices have been previously known in the art;however, for a variety of reasons, such devices have not been successfulin preventing, for example, the infection that often occurs in theperforated flesh, due to the ineffective sealing of the perforatedtissue from fluids contained in the peritoneal cavity. The known priorart insertion devices have also. not solved the persistent problem ofpreventing undue irritation in the perforation of the tissue, whethercaused by normal movement of the patient or necessary manipulation ofthe devices by those administering to the patient, thus necessitatingfrequent withdrawals of the ,device and a consequent loss ineffectiveness of the treatment. Further, these known prior art deviceshave required surgical implantation and subsequent suturing, in order tosimilarly achieve even the ineffective sealing previously experienced,and required surgery to remove the device.

Inflatable devices are also known which are4 designed to be used withina body. Devices of this nature are typified by the Wallace patent, No.2,667,875; however, these inflatable devices in general, and the Wallacecatheter in particular, do not effect any sealing of a perforation, butrather are to be used within a natural body cavity.

Accordingly, it is a principal objective of the present invention toprovide a cannula which effectively seals a perforation made in thetissue.

It is a further object of the present invention to provide a novelcannula which is adjustable, pressure-sensitive, self-retaining, andintroduced through standard trocars which is maintained substantiallyfree from contact with the perforated tissue.

Another object of the present invention is to provide a cannula whichcan seal a perforation and retain itself in position along with anytubular device inserted through the cannula irrespective of thte normalmovements of the patient.

A further object of the present invention is to produce tension in thecannula in order to draw the balloon attached to the end of the cannulatightly against the flesh surrounding the perforation.

This invention has as a further object the provision of a novel cannulawhich is self-adjusting when in position in a perforation and will beresponsive to increases in natural internal body pressures to effect agreater sealing with the lowest possible initial pressure against theflesh surrounding the perforation when positioning the cannula in thebody.

Another object of this invention is to provide a cannula having aballoon sealing means which can be collapsed beyond one end of thecannula, in order to permit the insertion of the cannula and balloonthrough a trocar having substantially the same internal diameter as theexternal diameter of the cannula.

A further object of the present invention is to provide a peritonealcannula in which the end of the cannula can be trimmed in accordancewith generally accepted surgical practice for an aseptic techniquewithout deflating the ice sealing balloon, and which is economical toproduce and disposable afte use.

These and other objects and advantages of the present invention willbecome apparent to those skilled in the art, from the followingdescription when read in conjunction with the accompanying drawing,wherein:

FIGURE 1 is a side elevational View of the peritoneal cannula, partlybroken away, according to the present invention, showing the cannula inposition through a perforation in body tissue;

FIGURE 2 is a cross sectional view along lines 2 2 of FIGURE l, showingparticularly the cannula holding and constriction assembly means and theinflated balloon embedded in position in the flesh surrounding theperforation;

FIGURE 3 is a cross sectional view on an enlarged scale taken alonglines 3 3 of FIGURE 2, and

FIGURE 4 is a perspective view of a modification of the flange portionof the cannula holding and constriction assembly means.

The present invention is a peritoneal cannula for positioning in aperforation in a body that includes a cannula holding and constrictionassembly means which is axially movable along one end of the cannula andwhich cooperates with an inflatable balloon surrounding a disc at theother end to retain the cannula inv a predetermined position about aperforation in the flesh and in which the balloon contacts the fleshonly at a distance from the :perforation in the flesh and isself-adjusting, depending upon the internal pressure in the body. Theholding and constriction means enables the cannula to be positioned byitself through a perforation in the flesh or may be used as an insertiondevice which receives a tubular element through the cannula and which,when in position, secures the tubular member to the cannula.

FIGURE 1 is 'a showing of the peritoneal cannula designated generally bythe numeral 10. The material of which the peritoneal cannula is composedshould be one that is flexible, easly sterilized and inexpensive, andmost importantly, one that will not irritate the flesh upon any contactbetween the cannula and the flesh. Also, it is important that uponinflation the balloon will not distort, but will assume thepredetermined shape. Accordingly, it has been found that the peritonealcannula should be made of plastic material, such as polyvinyl,polypropylene, or polyethylene. Also shown is a tubular element 12 whichmay have perforations 14 at one end and which may be used as a fluidwithdrawal or insertion device. The tubular element or tube 12 alsorepresents any one of a number of devices which can be used fortaking'measurements, photographs, a catheter for injecting orwithdrawing fluids, or otherwise treating interior portions of theperitoneal cavity.

The peritoneal cannula 10 includes a cannula 16 0f sufficient length tobe inserted into a perforation. At the end of the cannula 16 is providedan inflatable balloon 1S, which is shown to be ring-shaped; however,this shape is not critical, since the balloon should have aconfiguration depending upon the end outline of the perforation P in theflesh F. It is important for the balloon 18 to encompass the.perforation P and bear against the flesh F at the contact area 20surrounding the perforation, which, as shown is substantially removedfrom the perforation. A connecting disc 22, which may be annular, isprovided. This disc is secured at its inner circumference 24 to theflared end portion 26 of the cannula 16, in order to position theContact area Ztl of the balloon at a distance from the perforation. Thedisc, as shown in FIG- URE 2, is uniformly thinner in longitudinal crosssection than said balloon when said balloon is inflated.

The balloon 18 may be inflated by liquid such as saline solution throughlumen 27, which is suitably secured as by fusing to the lower sheet andis further connected to and passes through the disc 22 at 36.

The balloon 18 is shown to be formed of upper and lower sheets 28 and 30of plastic, which are fused at the outer circumference 32 of the innerannular portion forming the disc 22. The outer diameter of disc 22should be atleast one and one-half the diameter of the perforation, asbest shown in FIGURE 2.

In order to form the balloon 18, which may be of ring or toroidal orsimilar shape, it is desirable to use a flat piece of plastic for thelower sheet 30, and the upper sheet 28 should be Vacuum formed into araised curve prior to sealing the upper sheet to the lower sheet, inorder that the disc 22 may be more remote from the contact area 20, thusallowing greater depression of the disc by either internal body pressureor tension on the cannular Without the disc coming in contact with theperforated flesh. As shown the disc 22 is eccentrically positionedrelative to the balloon.

It is to be noted that the upper portion of the balloon forms a smoothcontact surface at 20 which avoids irregularities when the balloon isinflated. Because of the shape of this contact area, which may be curvedas shown, the contact area 20 of the balloon will embed into the fleshupon tensioning of the cannula. FIGURE 2 clearly shows this importantresult of the present invention. It can be seen that forming the balloonwith a depressed or fiat center, such as disc 22, permits the tissue toform greater contact with the balloon and thereby provide a greaterseal.

The disc 22, therefore, performs a Variety of functions, the firsthaving been described as enabling increased contact forming a secureseal between the balloon and the flesh at a point removed from theperforation; the second is to receive the lumen 27 for passage from theunderside of the balloonv into the perforation; the third is to providea strong connection between the inner edges of the balloon and thecannula which will enable the balloon and disc t-o be collapsed in frontof the cannula and to a size substantially the same as the diameter ofthe cannula, and thus not require a particularly large perforation; anda fourth is to increase the uncounterbalanced area responsive tointernal body pressure such that in-l creasing natural internal bodypressures, occurring as during coughing of the patient, will tend toseat the contact area further into the flesh and further allow sealingwith the lowest possible pressure of the contact area on the flesh andthe lowest possible tension on the cannula, thus enabling the peritonealcannula to be self-compensating and maintain proper sealing duringvariations in internal body pressure.

In order to maintain the cannula in position in the perforation P, thereis provided a cannula holding and constriction assembly means, showngenerally at 38 in FIG- URE 2. This assembly means is composed of aflange portion 40 which extends radially at least as far as the contactarea 20 of the balloon and thus provides its own contact area 42 inalignment with and directly opposed to the contact area 20 of theballoon. Thus it can be seen that pressure exerted upon the flange 40and maintained by the assembly means 38 will embed the balloon 18 andthe particular contact area 20 into the flesh, thus providing a moreeffective seal of the perforation P from the fluids in the peritonealcavity.

The cannula holding and constriction means includes a flange portion 40,which is provided with a neck 44 having threads 46 on its exterior. Theneck portion 44 is receiVed in a cap 48, which has internal threads. Theflange portion 40 and the cap 48 are axially movable along the cannula16 when cap 48 is in loosened posit-ion and are provided with grippingmeans and 52 on the cap and neck, respectively.

As best shown in FIGURE'Z, an O-ring 54 is positioned in the cannula andoperates to reduce the size of the passageway S6 in the cannula 16. Thediameter of the O- ring is slightly larger than the inside diameter ofthe cannula, and thus creates a protuberance 58 in the wall of thecannula. This protuberance is positioned with the gripping means 50 and52, located on either side, and when the cap 48 is in a non-tightenedposition, gripping means 58 and 52 are separated to such an extent thatthey are not both in contact with the protuberance. Accordingly, it ispossible for the entire assembly means 38, in-

cluding the O-ring 54, to move axially up and down the. Y-

cannula, since upon movement in any direction, one or the other of thegripping means will bear upon the O-ring through the cannula Wall. Asshown, the gripping means 50 and 52 cannot be separated to the extentthat the O- ring would be dislodged upon movement to a position in whichits axis is not coincident with the axis of the cannula.

Upon moving the cap 48 towards flange 40, gripping means S0 in the capwill come to bear upon the O-ring through the cannula wall and move theO-ring to a position in which it abuts gripping means 52 again throughthe wall. Further tightening of the cap will force cam surfaces 60 and62, positioned on gripping means 50 and 52, respectively, into adistorted condition, whereby the passageway S6 through the O-ring willbe substantially decreased in size. Such reduction in size of thepassage- Way will maintain any member-such as, for example, tubularmember 12-that may be inserted into the cannula firmly in place. Also,whether or not the tubular member 12 is present, the distortion of theO-ring and frictional engagement of the gripping surfaces and theiryrespective cams upon the sharp curves produced at the protuberance 58of the cam will prevent any axial movement of the assembly means 38.Thus the assembly means will maintain the pressure exerted by contactarea 42 upon the iiesh F, maintaining a tight seal at contact area 20around the balloon, which creates tension in the portion of the cannulabetween the O-ring and the balloon.

In use the peritoneal cannula may be easily and simply positioned Withina body through a normal trocar (not shown) by collapsing the balloonafter it has been deated by removing the fluid through the lumen 27 andcollapsing the disc 22. After the balloon has been inserted through thetrocar and int'o the perforation P, the balloon is to be inflatedthrough the lumen, preferably by liquid saline solution, and aktensionforce applied upon the cannula 16. This tension automatically positionsthe balloon around the perforation and at a suilcient distance from theedge of the perforation. With the cap 48 loosened so that the cannulaholding and constriction assembly means 38 may be moved axially alongthe cannula 16, the flange 40 with its contact area 42 may be moved intoplace in contact with the flesh to exert pressure against the fleshholding the cannula under tension, thereby causing contact area to seatin the flesh. With the flange 40 so held in position and withapplication of the proper amount of pressure to form a securing sealbetween the balloon and the flesh surrounding the perforation, the cap48 may be tightened, in order thatthe gripping means 50 and 52 withtheir cams 60 and 62 may frictionally engage the O-ring through cannula16 and maintain the assembly means 38 in position and maintain thepressure of the flange 40 and its contact area 42 as applied to theflesh. Upon tightening of the cap 48, the O-ring 54 will deform toreduce and constrict the passageway 56 to hold securely any member, suchlas tubular member 12, which is passed down through the cannula.Regardless of whether any tubular member such as 12 is positioned in thecannula, the pressure of the contact area 42 will be maintained. In theevent that no instrument is to be placed down through the cannula 16, acomplete closing of the cannula 16 can be accomplished by any suitableclamp or surgical cord (not shown), which deforrns the cannula 16 tocompletely close passageway 56.

As shown, the lumen 27 passes through disc 22 at 36 and into theperforation P and out beneath ange 40. It is also possible to provideliange 40a, as shown in FIGURE 4, having a slot 64, through which thelumen may pass. The liange 40a has a neck 44, as previously described.

It will be understood that there are numerous advantages of the presentinvention which have been already disclosed. In addition, it has beenfound that with the present cannula, any tube that is passed downthrough the cannula is not held rigidly, except by the O-ring, thusenabling the inner end of the tubular member, whether it hasperforations or whether it be a probe or sensor, to have some movementwhich is particularly advantageous in the event body fluids are to bedrained completely, since it is known that such uids often tend toaccumulate in pockets and are not necessarily in one location.

It is also important in that the cannula holding and constriction meansis adjustable, which enables the device to be used regardless of thewidth of the liesh and the length of the perforation, thus enabling thedevice to be used in small children, or large obese adults. Also, insituations of dialysis or other required entrances into a body cavity,the device, according to the present invention, eliminates therequirement of a re-puncture for each redialysis.

A further important advantage of the present invention is the fact thatthe device is so simple that it can be installed with a minimum ofpreparation. The training required to insert the peritoneal cannula,according to the present invention, can be obtained simply and easily.

A further advantage of the present invention is that the end of thecannula can be cut olf in accordance with common medical practicewithout the delia'tion of the balloon.

From the foregoing detailed description, it will be evi- -dent thatthere are a number of changes, adaptations, and

modifications of the present invention which come within the province ofthose skilled in the art. However, it is intended that all suchvariations not departing from the spirit of the invention, be consideredas within the scope thereof as limited solely by the appended claims.

We claim:

1. A cannula for sealing va perforation in flesh that forms a cavity ina body and for releasably securing to said `body comprising: anelongated cannula having a passageway, an iniiated balloon surroundingone end of said cannula, separate connecting .means secured to one endof said cannula and radially outwardly to said balloon, said balloonbeing positioned radially outwardly from said cannula at the point ofintersection of the balloon and said connecting means, said separateconnecting means being uniformly thinner in longitudial cross sectionthan said balloon when said balloon is inflated, said balloon inintiated condition having a radially outwardly extending surface facingthe other end of said cannula forming a first Contact area, a lumenextending substantially the length of the cannula and passing through atleast a portion of said connecting means and secured so as to be iniluid communication with said balloon, said iirst area bieng radiallyspaced from said cannula and adapted to be substantially spaced from theedges of said perforation by said separating means so as to provide airm contact between the balloon and the liesh, cannula holding meanspositioned on said cannula for axial movement along said cannula toimpart tension to said cannula in order to maintain said first areatightly against said flesh, said holding means including a secondcontact area facing said first area in order that pressure exerted bysaid second area towards rst area embeds said first area into the flesharound but substantially spaced from said perforation to effectivelyseal said perforation Afrom said cavity, and pressure maintaining meansincluded in said holding means for maintaining pressure of said secondarea towards said first area.

2. The cannula of claim 1, wherein the lumen is independent of saidcannula and passes entirely through said connecting means and is securedto the opposite side of said balloon from said first contact area.

3. The cannula of claim 1, wherein the connecting means is in the-formof a at flexible disc having a di.- ameter greater than that of theperforation.

4. The construction of claim 1, wherein the connecting means iseccentrically positioned on said balloon and is remote from the iirstcontact area to permit greater depression of said connecting meanswithout contact with the iiesh.

5. A cannula for sealing a perforation in flesh that forms a cavity in abody and for releasably securing to said body, comprising: an elongatedcannula having a passageway, an inflated balloon surrounding one end ofsaid cannula, connecting means securing said balloon to said cannula,said connecting means extending radially 1outwardly 'of said cannula toincrease the effective pressure area of Isaid balloon, said connectingmeans being in the form of a ilat disc secured to the end of the cannulato permit the balloon to be folded .to have a diameter substantially thesame as the diameter of the cannula, said balloon in iniated conditionhaving a radially extending surface facing the other end of said cannulaforming a first contact area, a lumen independent of said cannulaextending substantially the length of said cannula and passing throughsaid connecting means and being on the opposite side of said balloon,said iirst area being spaced from said cannula and adapted to be spacedfrom the area of said perforation, cannula holding and constrictionassembly means positioned on said cannula for axial movement along saidcannula to impart tension to said cannula in order to maintain saidtirst area tightly against said flesh and to constrict the passageway,said assembly means including a second contact area `facing said firstarea in order that pressure exerted by said second area towards saidirst area embeds said first area into the iiesh around said perforationto effectively seal said perforation, and pressure maintaining meansincluded in said assembly for maintaining pressure of said second areatowards said first area.

6. A cannula for sealing a perforation in flesh that forms a cavity in abody and for releasably securing to said body, comprising: an elongatedcannulahaving a passageway, an inflatable balloon surrounding one end ofsaid cannula, connecting means securing said balloon to said cannula,said connecting means extending radially outwardly from said cannula toincrease the effective pressure area of said balloon, said balloon ininflated condition having a radially extending surface facingthe otherend of said cannula forming a 'first contact area, said lirst area beingspaced from the cannula and adapted to be spaced from the edges of saidperforation, means for liuid communication with said balloon, cannulaholding and constriction assembly means positioned on said cannula foraxial movement along said cannula to impart tension to said cannula inorder to maintain said first area tightly against said lies-h and toconstrict the passageway, said assembly means including a second contactarea facing said first area in order that pressure exerted by saidsecond area towards said first area embeds said rst area into the esharound said perforation to effectively seal said perforation, pressuremaintaining means included in said assembly for maintaining pressure ofsaid second area towards said first area, means for reducing thediameter of said passageway, said means for reducing including aresilient member slidably positioned withinsaid passageway and grippingmeans on the exterior of said cannula for gripping said resilient memberthrough the wall of said cannula to reduce the effective diameter of thepassageway and maintain the rst area embedded in the flesh and thecannula in tension.

i 7. A cannula for sealing a perforation in flesh that forms a cavity ina body and for releasably securing to said body, comprising: anelongated cannula having a passageway, an infiatable balloon surroundingone end of said cannula, connecting means securing said balloon to saidcannula, said connecting means extending radially outwardly from saidcannula to increase the effective pressure area of said balloon saidballoon in inflated condition having a radially extending surface facingthe other end of `said cannula forming a first contact area, said firstarea being spaced from the cannula and adapted to be spaced from theedges of said perforation, means for fluid communication with saidballoon, cannula holding and constriction assembly means positioned onsaid cannula for axial movement along said cannula to impart tension tosaid cannula in order to maintain said first area tightly against saidflesh and to constrict the passageway, said assembly means including asecond contact area facing said first area in order that pressureexerted by said second area towards said first area embeds said firstarea into the flesh around said perfo-ration to effectively seal saidperforation, pressure maintaining means included in said assembly formaintaining pressure of said second area .towards said first area, saidassembly means including means for reducing the size of said passageway,said means for reducing including a resilient member slidably positionedwithin said passageway and gripping means on the exterior of saidcannula for gripping said resilient member through the wall of saidcannula to simultaneously reduce the effective diameter of thepassageway and maintain the first area embedded in ythe flesh and thecannula in tension, one of said gripping means being positioned onopposite side of said resilient member from another of said grippingmeans for movement toward and away from said other gripping means andsaid resilient member.

8. An insertion device including a cannula for sealing a perforation inflesh that forms a cavity in a body and for releasably securing to saidbody, comprising: an elongated cannula having a passageway, aninflatable balloon surrounding one end of said cannula, connecting meanssecuring said balloon to said cannula, said connecting means extendingradially outwardly from said cannula to increase the effective pressurearea of said balloon, said balloon in inflated condition having a -radially extending surface facing the other end of said cannula forming afirst contact area, said first area being spaced from the cannula andadapted to be spaced from the edges of said perforation, means for fluidcommunication with said balloon, cannula holding and constrictionassembly vmeans positioned on said cannula for axial movement along saidcannula to impart tension to said cannula in order to maintain said rstarea tightly against said flesh and to constrict the passageway, saidassembly means including a second contact area facing said first area inorder that pressure exerted by said second area towards said first areaembeds said first area into the flesh around said perforation toeffectively seal said perforation, pressure maintaining means includedin said assembly for maintaining pressure of said second area towardssaid first area, and a tube within said cannula passing through saidconnecting mean-s, means for reducing the diameter of said passageway toretain said tube in position, said means for reducing including aresilient member slidably positioned within said passageway and grippingmeans on the exterior -of saidcannula for gripping said resilient memberthrough the wall of said cannula to simultaneously reduce the effectivediameter of the passageway and maintain the first area embedded in theflesh and the cannula'in tension, one of said gripping means beingpositioned on the opposite side of resilient member from another of saidgripping means for movement toward and away from said Vother grippingmeans and said resilient member.

9. The construction of claim 8, wherein said second area includes a fiatfiange portion in contact alignment with ysaid first area.

10. An insertion device including a cannula for sealing a perforation inflesh that forms a cavity in a body and for releasably securing to saidbody,comprising: an elongated cannula having a passageway, an infiatableballoon surrounding one end of said cannula, connecting means securingsaid balloon to said cannula, said vballoon in inflated condition havinga radially extending surface facing the other end of said cannulaforming a first contact area, said first area being spaced from thecannula and adapted to be spaced from the edges of said perforation,saidconnecting means being a substantially flat disc extending outwardlyfrom said cannula to increase the effective pressure area of saidballoon, said disc being eccentrically positioned on said balloon andremote from said first contacted area to avoid contact to the fleshadjacent the perforation, a lumen independent of said cannula extendingsubstantially the length of the cannula passing through said connectingmeans and secured to the opposite side of said balloon `to provide fiuidcommunication with said balloon, cannula holding means postioned on saidcannula for axial movement along said cannula to impart tension to saidcannula in order to maintain said first area tightly again-st saidflesh, said assembly means including a second contact area facing saidfirst area in order that pressure exerted by said second area towardssaid first area embeds said first area into the flesh around saidperforation to effectively seal said perforation, pres- Isuremaintaining meansincluded in said assembly for maintaining pressure ofsaid second area towards said first area, a tube within said cannulapassing through said connecting means, and said pressure maintainingmeans including gripping means frictionally engaging said cannula f-orholding said assembly in a predetermined position along said cannula.

References Cited by the Examiner UNITED STATES PATENTS 2,324,520 7/1943Lamson 128-1 2,586,940 2/1952 Graham 12S-349 2,667,875 2/1954 Wallace128-349 2,898,917 8/1959 Wallace 128-350 3,039,468 6/1962` Price 12S-348 FOREIGN PATENTS 179,842 10/1954 Austria.

676,943 12/ 1929 France. 19,196 1906 Great Britain.

134,367 11/1919 Great Britain.

141,591 1/1961 Russia.

RICHARD A. GAUDET, Primary Examiner.

v DALTON L. TRULUCK, Assistant Examiner.

1. A CANNULA FOR SEALING A PERFORMATION IN FLESH THAT FORMS A CAVITY INA BODY AND FOR RELEASABLY SECURING TO SAID BODY COMPRISING: AN ELONGATEDCANNULA HAVING A PASSAGEWAY, AN INFLATED BALLOON SURROUNDING ONE END OFSAID CANNULA, SEPARATE CONNECTING MEANS SECURED TO ONE END OF SAIDCANNULA AND RADIALLY OUTWARDLY TO SAID BALLOON, SAID BALLOON BEINGPOSITIONED RADIALLY OUTWARDLY FROM SAID CANNULA AT THE POINT OFINTERSECTION OF THE BALLOON AND SAID CONNECTING MEANS, SAID SEPARATECONNECTING MEANS BEING UNIFORMLY THINNER IN LONGITUDINAL CROSS SECTIONTHAN SAID BALLON WHEN SAID BALLOON IS INFLATED, SAID BALLOON IN INFLATEDCONDITION HAVING A RADIALLY OUTWARDLY EXTENDING SURFACE FACING THE OTHEREND OF SAID CANNULA FORMING A FIRST CONTACT AREA, A LUMEN EXTENDINGSUBSTANTIALLY THE LENGTH OF THE CANNULA AND PASSING THROUGH AT LEAST APORTION OF SAID CONNECTING MEANS AND SECURED SO AS TO BE IN FLUIDCOMMUNICATION WITH SAID BALLOON, SAID FIRST AREA BEING RADIALLY SPACEDFROM SAID CANNULA AND ADAPTED TO BE SUBSTANTIALLY SPACED FROM THE EDGESOF SAID PERFORATION BY SAID SEPARATING MEANS SO AS TO PROVIDE A FIRMCONTACT BETWEEN THE BALLOON AND THE FLASH, CANNULA HOLDING MEANSPOSITIONED ON SAID CANNULA FOR AXIAL MOVEMENT ALONG SAID CANNULAR TOIMPART TENSION TO SAID CANNULAR IN ORDER TO MAINTAIN SAID FIRST AREATIGHTLY AGAINST SAID FLESH, SAID HOLDING MEANS INCLUDING A SECONDCONTACT AREA FACING SAID FIRST AREA IN ORDER THAN PRESSURE EXERTED BYSAID SECOND AREA TOWARDS FIRST AREA EMBEDS SAID FIRST AREA INTO THEFLESH AROUND BUT SUBSTANTIALLY SPACED FROM SAID PERFORATION TOEFFECTIVELY SEAL SAID PERFORATION FROM SAID CAVITY, AND PRESSUREMAINTAINING MEANS INCLUDED IN SAID HOLDING MEANS FOR MAINTAININGPRESSURE OF SAID SECOND AREA TOWARDS SAID FIRST AREA.